Helsinki, Finland (5 April 2005) -- Ipsat Therapies, a Finnish biopharmaceutical company with a novel approach to fighting hospital acquired infections and antibiotic resistance, today announced positive Phase IIa clinical trial data for its lead product, P1A. The product is designed to inactivate beta-lactam antibiotics in the lower intestinal tract, post bloodstream absorption. The results were presented at the 15th ECCMID in Copenhagen, the premier European conference for infectious diseases.
The Phase IIa study showed P1A, when given over a period of five days concurrently with ampicillin, a beta-lactam antibiotic, prevented the emergence of bacterial antibiotic resistance and depletion of healthy intestinal microflora, side effects commonly associated with antibiotic treatment. An excellent safety profile was also demonstrated in all patients treated with P1A. The next stage will be a Phase IIb study to further evaluate the efficacy of P1A in the hospital setting.
Dr Marion Carson, Managing Director at Ipsat, commented on the results: There is a need to halt the emergence and spread of antibiotic resistance. This is a new and promising strategy which would ultimately result in prolonging the efficacy of our current antibiotic portfolio and may also be applicable for new antibiotics.
Resistance development during prolonged intestinal exposure to antibiotic coupled with the depletion of the protective intestinal microflora culminates in the often aggressive colonization by pathogenic microbes. Current hospital hygiene strategies are generally unsuccessful at prevention. This problem presents hospitals with increasing challenges where infection containment and economic consequences are already a serious burden. The total costs related to antibiotic resistant organisms are approximately US$30 billion in the USA today.
P1A effectively prevented all changes for the entire duration of antibiotic use and demonstrated definitive proof of concept for Ipsat´s novel approach. Further, the results clearly mirror those published earlier from preclinical in vivo studies. This allows us to efficiently test our next generation products in the future with the same clinical model, commented Tuula Heinonen, PhD, Director R&D at Ipsat.
-Ends- NOTES TO EDITORS: 1B-lactam Antibiotics A gold standard (GS) class of antibiotics, accounting for 47% of the top ten selling products in a US$26 billion market. Bacterial resistance in hospital acquired infections (HAI) is the biggest problem related to GS antibiotics. The annual cost for treating antibiotic resistant infections is approximately US$30 billion in the US alone.
2Hospital Acquired Infections
Treatment of hospital acquired infections accounts for an additional US$4 billion in healthcare costs in the US alone with a 35% mortality rate. Commonly known resistant pathogens resulting in these serious infections include Clostridium difficile, vancomycin-resistant Enterococci and other gram negative bacteria, as well as aggressive yeasts such as Candida glabrata.
3Ipsat Therapies
Ipsat Therapies Ltd is a private company focusing on the development of products in the anti-infective field. Ipsat´s focus is primarily on the development of products for the prevention of antibiotic resistance, antibiotic-associated diarrhoea and hospital associated infections. The Company became operational in 1999 and has raised €19 million in funding to date. For more information please visit http://www.ipsat-ther.com.
FOR MORE INFORMATION, PLEASE CONTACT:
Dr Marion Carson
CEO
Ipsat Therapies
Viikinkaari 4,
FIN-00790 Helsinki
Finland
Tel: +358 (0)40 9030082
Email: marion.carson@ipsat-ther.com
www.ipsat-ther.com
